The legal relationship between physicians and their patients can be characterized in different ways depending on the circumstances establishing their association with one another and the complained of actions by the doctor. The way in which the relationship is characterized in law impacts the potential causes of actions and remedies available.
The most common relationship is that of “doctor and patient” in the provision of medical care and the subsequent claims based on breach of contract or negligence. Doctors can, however, be found to be fiduciaries based on the concepts of trust and vulnerability. The consequence of such a finding leads to a much different legal analysis than is the case for a malpractice claim. As it is an equitable remedy it must be determined by a judge and not a jury. Secondly, and more critically, it does not require the plaintiff to prove causation. Causation is often where plaintiffs’ claims in negligence flounder.
Case In Point:
A case illustrating this point is the recently released decision of the Ontario Superior Court of Justice: Stirrett v. Asim Nazir Cheema et al. The pleadings advanced claims in both negligence and breach of fiduciary duty. The allegations of fact made in support of both causes of action mirrored one another. The plaintiff was the wife of a patient who had died following a research study based angiogram performed on February 10, 2005. The target defendant was the interventional cardiologist behind the study.
The deceased husband suffered from non-insulin dependent, Type II diabetes. He underwent an angioplasty on June 11th, 2004 to relieve a 90% blockage (stenosis) in his left circumflex artery. The procedure places a metal stent within the area of blockage to increase blood flow to the heart. The procedure was successful.
Before the June 2004 procedure, the deceased was suddenly approached by a nurse and asked to voluntarily participate in a study. He would have to self-inject insulin and undergo a follow up angiogram in six months. The risk of injury from such a procedure (heart, attack, stroke or death) was 1/1000. He was told the study was funded by the Heart and Stroke Foundation and that it involved 240 patients. He agreed to participate and signed a consent form..
A common problem following such procedures is restenosis (where the artery begins to narrow and again restrict blood flow). Interventional cardiologists had recognized that restenosis occurs more often in diabetics. The defendant doctor proposed a study to determine if “intensive control of glucose levels with insulin” would lead to a reduce level of restenosis especially in diabetics. It was called the STREAM study. Funding was sought and obtained from the Heart & Stroke Foundation on certain conditions.
Scientific Research on Humans:
Such studies must comply with certain ethical requirements as set out in the Tri-Council Policy. In addition all hospitals conducting such research implement their own Research Ethics Boards (REB) who provide permission for the work to commence or continue. All this was in addition to the protocol established for the study itself, the critical requirements being:
- A sample size of 240 participants (the minimum number to make the results statistically relevant so as to not risk the safety of any more patients than necessary);
- A Data Safety Monitoring Board (DSMB)(to oversee the usefulness of the data and the safety of the patient participants);
- The consent form would provide a “full and frank disclosure of all information relevant to a free and informed consent.”
The Studies Deficiencies:
The Heart and Stroke Foundation ceased funding the project in the fall of 2003 as there were two few participants (55) making the results statistically invalid. Despite this, the defendant persisted in recruiting volunteers including the deceased. The goal now was to find 100 patients in total, not 240. This was done without approval of the hospitals REB. In addition a DSMB was never established. Despite all these changes to the study no alteration was made to the consent form presented to the deceased. In addition the consent form promised that “any new information about the study which might influence your willingness to (continue) to participate in the study would be disclosed by your doctor”. No new information was provided to the deceased, he was not told of the changes to the study already in existence at the time he signed the consent form.
The tort of negligence requires a plaintiff to allege and prove four elements. They are a duty of care, a breach of the standard of care, a foreseeable injury caused by the breach and finally the damages suffered as a result.
The jury found the defendant cardiologist to have breached the standard of care. They did so by reason of his failure to advise of the change in sample size, to set up a DSMB, to update the consent form and finally to obtain REB approval.
However the jury found that these failures were not the cause of the deceased undergoing the fatal angiogram. The trial judge speculated that they did so because of the low risk of the procedure, and that it’s better to know if restenosis was present, which in fact it was. That finding precluded any damages being awarded for his negligence. Had this been the only claim advanced the action would then have been dismissed.
Whether one existed was for the trial judge alone to determine as it was an equitable remedy. Such a duty is not normally found within the usual doctor-patient relationship. That is why no fiduciary duty was found for the doctors who performed the fatal angiogram.
The relationship, however, of the defendant cardiologist was one of both doctor-patient and researcher-patient. The duty of a doctor in such a position was one of full and frank disclosure which a reasonable man might be expected to consider before giving his consent based on the decision in Halushka v. University of Saskatchewan. Such an obligation made a doctor who did not provide full and frank disclosure a fiduciary.
The court in this case distinguished the Ontario Superior Court decision of McDonald-Wright (Litigation Guardian of) v. O’Herlihy as before this court there were findings of negligence by the jury. The duty having been established, it was breached by the failure to comply with the terms set out in the consent form. While it may be that the changes necessary to fulfill the duty were not significant or would have materially changed the risk of harm, they had to be disclosed. Had they been, the duty would not have been breached. A duty and breach having been found of a fiduciary obligation eliminated the need to establish causation.
It is almost certain the decision will be appealed. The similarities to the McDonald-Wright decision, except for the findings of negligence by the jury and the existence of a researcher-patient relationship are striking.
In both cases the claims appear to have been pleaded and fought as negligence cases. In both cases a fiduciary duty was pleaded, but the allegations of breach essentially mirrored the allegations of negligence. The decision of the Supreme Court of Canada in Arndt v. Smith was not considered here but was in McDonald Wright. It was also a malpractice case dealing with non-disclosure and opined:
… “I would reject the alternative approach of fiduciary obligation proposed by the respondent…. the effect would be to replace the factual analysis of standard of care and causation appropriate to negligence actions with a choice- based analysis that makes recovery virtually automatic upon proof of failure to provide relevant information. I see no reason to depart from the approach which considers the failure of a physician to advise of medical risks under the law of negligence relating to duty of care, absent special circumstances like fraudulent misrepresentation or abuse of power for an unprofessional end … Such conduct is neither alleged nor proven in the case at bar.”
In addition, the trial judge here acknowledged that not all researcher-patient relationships were fiduciary in nature. It is that characterization here, however, that led to a recovery by the plaintiff.
Note that Valerie Wise, founder of Wise Health Law, was requested to comment on the decision in the Law Times.
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